NitiNotes' EndoZip System for the Treatment of Obesity

Exclusion Criteria

• •1. Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis.
• •2. Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
• •3. Uncontrolled diabetes or change in diabetes medication and/or dosage in the 3 months prior to enrolment
• •4. Uncontrolled hypertension
• •5. Subject with heart failure, NYHA grade 2 and above.
• •6. Subject has pre-existing respiratory disease, such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
• •7. Subject has significant esophageal disease including Zenker's diverticulum, severe gastro-esophageal reflux disease (GERD), stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility, which is not controlled with medication.
• •8. Subject has renal and/or hepatic insufficiency/disease (creatinine above 1.5 mg/dL)
• •9. Subject has thyroid disease, which is not controlled with medication.
• •10. Subject is diagnosed with ostocorticular pain, pre-neoplastic lesions or coagulation conditions that may prevent him/her from undergoing a surgical procedure.
• •11. Subject has a history of intestinal strictures or adhesions and/or any condition that could preclude passage of endoluminal instruments.
• •12. Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to device use), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
• •13. Subject is diagnosed with a coagulation disorder.
• •14. Subjects undergoing chronic steroid therapy.
• •15. Subjects undergoing immunosuppressive therapy.
• •16. Subjects who cannot discontinue either prescription or over the counter weight loss medications for at least 30 days prior to the procedure as well as during the trial period.
• •17. Subjects who have known hiatal hernias greater than 5 cm.
• •18. Subjects who have poorly controlled psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or suicidal tendencies.
• •19. Subject has active Crohn's disease or Colitis.
• •20. Subject currently uses or has a history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
• •21. Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within 6 months prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study and their participation may interfere with the current study.
• •22. Subject has any condition that, at the discretion of the investigator, would preclude participation in the study.
• •23. Unstable diabetes patients who are treated with insulin.